Device product
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Z-1286-2023
Product summary
- Event
- Event 91745
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 kits
- Official record key
device-enforcement:Z-1286-2023
Official wording
Reason: The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Code information: GTIN: 05055273201765 Batch: 588434
Distribution pattern: PA, OH, WV
Derived failure modes
-
Unknown
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range